Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions

The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hair Diseases Hirsutism Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Virilism

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.

Treatment and study plan

Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

Drug

Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)

Drug

Primary outcomes

Bioequivalence based on AUC and Cmax

Time frame: 11 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

Randomized, Open-Label, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex (Reference) Following a 50 mg Dose in Healthy Subjects Under Fed Conditions.

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Aug 17, 2009
Registry last updated: Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed